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. 2021 Dec 15;35(Suppl 2):S183-S188.
doi: 10.1097/QAD.0000000000003092.

Weight gain stopping/switch rules for antiretroviral clinical trials

W D Francois Venter  1 , Simiso Sokhela  1 , Alexandra Calmy  2 , Luckyboy Mkhondwane  3 , Bronwyn Bosch  1 , Nomathemba Chandiwana  1 , Andrew Hill  4 , Kenly Sekwese  5 , Nkuli Mashabane  1 , Anton Pozniak  6 , Saye Khoo  4 , Mohammed Ali  7 , Eric Delaporte  8 , Samanta Lalla-Edwards  1 , Polly Clayden  9 , Vincent C Marconi  10 , Mark J Siedner  11 , Marta Boffito  12 , Celicia Serenata  1 , Mary Carman  13 , Simon Collins  9
Affiliations

Weight gain stopping/switch rules for antiretroviral clinical trials

W D Francois Venter et al. AIDS. .

Abstract

Obesity develops in a substantial number of people initiating and maintaining modern antiretroviral therapy. The comorbidities associated with obesity make significant weight gain and metabolic changes a major consideration in clinical trials studying different regimens' potency and safety. It is as yet unclear what role individual antiretrovirals or classes play in weight gain but the issue is a complex one for clinical trial design, especially when deciding when "too much" weight has been gained, in a context where we do not yet know if switching to alternative regimens will slow, halt or reverse weight gain or metabolic changes. In addition, clinician and trial participant opinion on acceptable weight gain may differ. We offer preliminary guidance for discussion for future antiretroviral clinical trial design.

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References

    1. Jackson CL, Wang NY, Yeh HC, et al.,. Body-mass index and mortality risk in U.S. blacks compared to whites. Obesity (Silver Spring). 2014. March;22(3):842–5 - PMC - PubMed
    1. Flegal KM, Kit BK, Orpana H, Graubard BI. Association of all-cause mortality with overweight and obesity using standard body mass index categories: a systematic review and meta-analysis. JAMA 2013;309:71–82. - PMC - PubMed
    1. Klatsky AL, Zhang J, Udaltsova N, et al., Body Mass Index and Mortality in a Very Large Cohort: Is It Really Healthier to Be Overweight? Perm J. 2017;21:16–142 - PMC - PubMed
    1. NCD Risk Factor Collaboration. Worldwide trends in body-mass index, underweight, overweight, and obesity from 1975 to 2016: a pooled analysis of 2416 population-based measurement studies in 128.9 million children, adolescents, and adults. Lancet 2017;390:2627–2642 - PMC - PubMed
    1. Flegal KM, Ioannidis JPA, Doehner W. J Cachexia Sarcopenia Muscle. Flawed methods and inappropriate conclusions for health policy on overweight and obesity: the Global BMI Mortality Collaboration meta-analysis, 2019. February;10(1):9–13. doi: 10.1002/jcsm.12378 - DOI - PMC - PubMed

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